MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DISPOSABLE MIXING BOWL AND SPATULA; PROSTHESIS, HIP

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2022

Event Type  malfunction  

Event Description

It was reported upon inspection in the japan warehouse, team member found debris in sterile package.No patient involvement.No additional information.

Manufacturer Narrative

(b)(4).Foreign source: japan.Complaint sample was evaluated and the reported event was confirmed.Visual review for disposable with spatula mixing bowl [item 00504901100 lot 65458625] confirms (1) pouch with one piece of loose blue debris.Debris exceeds.60 sq.Mm.Visual review for disposable with spatula mixing bowl [item 00504901100 lot 65459017] confirms a total of (7) pouches with debris.(4) pouches have one piece of loose blue debris exceeding.60 sq.Mm.(1) pouch has three pieces of loose blue debris of those two pieces exceed and one piece is less than.60 sq.Mm.(1) pouch has four pieces of loose blue debris all exceeding.60 sq.Mm.(1) pouch has one piece of loose dark debris exceeding.60 sq.Mm.Device history record (dhr) was reviewed and no discrepancies were found.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.The likely condition of the product when it left zimmer biomet was non-conforming.The root cause of the reported event is the operator not following the work instructions provided.A corrective action has been previously initiated for the reported event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001526350 - 2022 - 01056, 0001526350 - 2022 - 01057, 0001526350 - 2022 - 01058, 0001526350 - 2022 - 01059, 0001526350 - 2022 - 01060, 0001526350 - 2022 - 01062, 0001526350 - 2022 - 01063.

• Brand Name: DISPOSABLE MIXING BOWL AND SPATULA
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15708953
• MDR Text Key: 302804248
• Report Number: 0001526350-2022-01061
• Device Sequence Number: 1
• Product Code: JDZ
• UDI-Device Identifier: 00889024376564
• UDI-Public: (01)00889024376564(17)270502(10)65459017
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00504901100
• Device Lot Number: 65459017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1